Patient Monitor User Manual Product Specification
- 264 -
Transient operating Temperature
The device operates according to specification when
exposed to -20
°C to 0 °C (-4 ℉ to 32 ℉) for 20
minutes.
Warm up time after storage at −
40 °C
A warm up period of 10 minutes is required for the
NomoLine ISA CO
2
module to fulfill the accuracy
specification if immediately put into use after being stored
at
−40 °C (A power on reset is required if a hardware error
is generated during the warm up period after being stored
at
−40 °C).
Ambient CO
2
≤ 800 ppm (0.08 vol%)
Mechanical robustness
Meets the shock and vibration requirements for transport of
EN ISO 80601-2-55:2011 clause 201.15.3.5.101.2 and EN
60601-1-12: 2015 clause 10.1.3
Recovery time after defibrillator
test
Unaffected
Drift of measurement accuracy No drift
Water handling
NomoLine Family sampling lines with proprietary water
removal tubing.
Sampling flow rate
(50 ± 10) sml/min
Note: 1. Volumetric flow rate of air corrected to standardized
conditions of temperature and pressure.
2. Flow accuracy specification for the extended temperature range
(-20 to 0 °C) is +15/-10 sml/min.
Breath detection
Adaptive threshold, minimum 1 vol% change in CO
2
concentration.
Respiration rate
0 to 150
± 1 breaths/min. (Measured at I/E ratio 1:1
using breath simulator according to EN ISO 80601-2-55
fig. 201.101.)
Fi and ET
FiCO
2
and EtCO
2
are displayed after one breath and have a
continuously updated breath average.
The following method is used to calculate end-tidal (ET)
values:
- The highest concentration of CO
2
during one breathing
cycle with a weight function applied to favor values closer
to the end of the cycle.
EtCO
2
will typically decrease below nominal value
(ET
nom
) when respiration rate (RR) exceeds the RR
threshold (RR
th
) according to the following formula:
(with NomoLine HH Adult/Pediatric Airway Adapter Set -
REF 3827)
Measured according to EN ISO 80601-2-55.
Sensor head
Dual channel NDIR type gas analyzer measuring at 3.5 to
4.5 μm. Data acquisition rate 10 kHz (sample rate 20 Hz /
channel).